Awake Endotracheal Intubation in Cervical Injury

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05619965
Collaborator
(none)
100
2
4

Study Details

Study Description

Brief Summary

The researcher will compare awake endotracheal intubation with glidescope video assisted laryngoscope vs fiberoptic bronchoscope in patients with traumatic cervical injury;

Condition or Disease Intervention/Treatment Phase
  • Drug: sedative
  • Device: Awake endotracheal intubation by Glidescope videolaryngoscope
  • Device: Awake endotracheal intubation by Fiberoptic bronchoscope
N/A

Detailed Description

One hundred patients undergoing post traumatic cervical spine fixation under general anesthesia will be randomly allocated to two groups in a prospective study. Between December 2022 and May 2023.

All patients will be premedicated before the procedure and after giving 500 ml of lactated ringer solution with glycopyrrolate 0.2 mg iv and dexmedetomidine 1 mic/kg IV over 10 minutes then 0.4 mic/kg/h continuous IV infusion. All patients will receive standard clinical care monitoring including three lead ECG, noninvasive arterial blood pressure measurement and pulse oximeter. Patient will be administered oxygen 6 L/min through nasal prong.

Patients will be allocated into two equal groups (50 patients per group) for awake intubation with either FOB (F group) or GVL (G group) according to computer generated randomization technique. Each patient will receive nebulization with 5 ml of lidocaine 1% for 5 min followed by topicalization of soft palate and fauces with 5 puffs of lidocaine spray (10 mg/spray) immediately before the technique of endotracheal intubation (ID 6.5 mm for female and 7 mm in male, armored tube. Before airway manipulation each patient will receive a bolus dose of fentanil 1 mic/kg.

During the procedure Philadelphia cervical collar will be removed and MILS of cervical spine will be carried out by trained assistant (senior registrar anesthetist, 5 years' experience). After successful intubation (by consultant anesthesia who had more than 100 times successful intubation with either FOB or GVL) and neurological assessment (by spinal surgeon), general anesthesia will be induced with propofol 1.5 mg/kg, cisatracurium 0.1 mg/kg and remifentanil 0.5 lg/kg. Hypotension (decreased in MAPP 20% of base line) will be treated with ephedrine bolus 5-10 mg and 250 ml of lactated ringer solution. Only three attempts will be permitted per each patient and if failed plan B was to carry out endotracheal intubation under inhalational induction with FOB without neuromuscular blockade and to exclude patients from the study. Attempt will be held if O2 saturation decreased below 90%.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The investigators will compare awake endotracheal intubation with glidescope video assisted laryngoscope vs fiberoptic bronchoscope in patients with traumatic cervical injuryThe investigators will compare awake endotracheal intubation with glidescope video assisted laryngoscope vs fiberoptic bronchoscope in patients with traumatic cervical injury
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Awake Endotracheal Intubation With Glidescope Video Assisted Laryngoscope vs Fiberoptic Bronchoscope in Patients With Traumatic Cervical Injury; Randomized Controlled Trial
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Awake Glidoscope Videolaryngoscope

Awake endotracheal intubation of cervical trauma patients by Glidoscope Videolaryngoscope

Drug: sedative
dexmedetomidine 1 mic/kg IV over 10 minutes then 0.4 mic/kg/h continuous IV infusion

Device: Awake endotracheal intubation by Glidescope videolaryngoscope
Awake endotracheal intubation by Glidescope videolaryngoscope of cervical trauma patient

Active Comparator: Awake Fiberoptic bronchoscope

Awake endotracheal intubation of cervical trauma patients by Fiberoptic bronchoscope

Drug: sedative
dexmedetomidine 1 mic/kg IV over 10 minutes then 0.4 mic/kg/h continuous IV infusion

Device: Awake endotracheal intubation by Fiberoptic bronchoscope
Awake endotracheal intubation by Fiberoptic bronchoscope of cervical trauma patient

Outcome Measures

Primary Outcome Measures

  1. intubating time [immediately post endotracheal intubation]

    (defined as the time from introduction of the scope till confirmation of correct endotracheal tube placement with three waves endtidal capnography)

  2. intubating attempts [immediately post endotracheal intubation]

    intubating attempts per each patient (will be recorded by dedicated technician).

Secondary Outcome Measures

  1. heart rate [immediately post endotracheal intubation]

  2. mean arterial blood pressure [immediately post endotracheal intubation]

  3. patient satisfaction (score; excellent =1, good =2 and fair = 3). [immediately post endotracheal intubation]

    (score; excellent =1, good =2 and fair = 3).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ASA I-II patients

  • ages 26-44

  • undergoing a selective cervical spine fixation.

Exclusion Criteria:
  • body mass index (BMI) more than 35 kg/m2.

  • Obstructive airway disease

  • cardiovascular disease

  • apparent airway difficulty

  • patient refusal .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mona Mohamed Mogahed, Associate professor, Tanta University
ClinicalTrials.gov Identifier:
NCT05619965
Other Study ID Numbers:
  • 35636/8/22
First Posted:
Nov 17, 2022
Last Update Posted:
Dec 2, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 2, 2022